Clinical Evaluations

Clinical Evaluation

A Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are two of the most critical documents for medical devices in European regulatory submissions. They are formal documents that thoroughly summarise, evaluate, and analyse clinical data related to a medical device, examining its safety and performance over the course of its intended use. Medical device manufacturers must develop CEPs and CERs to demonstrate the device’s clinical safety and effectiveness, ensuring compliance with strict regulatory requirements.

These documents are required for all medical devices that will be CE or UKCA marked and for other international markets such as Australia.

Experienced and reliable support

JReg will start by allocating you a dedicated medical writer with clinical experience in your device’s field of use. Your clinical writer will work with you to develop a comprehensive assessment of the device’s safety and performance profile, clinical evidence, and an evaluation of clinical sufficiency before submitting files to the notified or approved body.

JReg can help your team understand the Medical Device Regulation (MDR) requirements on clinical evaluations and work in collaboration to support development of in-house processes and documentation to meet clinical requirements including Post Market Surveillance Plans and Reports, in addition to Periodic Safety Reports.

JReg is pleased to use MedBoard, as part of our commitment to deliver effective regulatory and clinical consulting services to our valued clients.

Medboard provides a single, comprehensive platform which allows our medical writers to track the literature review process, managing tasks in a more efficient and cost-effective manner for our clients. This allows us to keep a competitive edge while meeting global compliance standards.

Keeping up with regulatory changes is a time-consuming task. MedBoard offers JReg a structured way to manage regulatory intelligence on behalf of our clients.

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Frequently Asked Questions

A Clinical Evaluation Report (CER) is a regulatory requirement for all medical devices seeking CE or UKCA marking. It provides a structured analysis of clinical data to demonstrate the device’s safety and performance. Without a compliant CER, market approval in the EU, UK, and other regions may be delayed or denied.

CERs are mandatory for devices under the EU MDR and UK regulations. Other international markets, such as Australia, may also require similar clinical documentation as part of their submission process.

Yes. We can create a full CER from scratch or review and update an existing one to ensure compliance with the latest standards.

Our clinical writers work with pre-market clinical investigations, published scientific literature, post-market surveillance data, and data from equivalent or similar devices to establish a robust clinical evidence base.

Absolutely. We support the design, documentation, and execution of PMCF Plans and Reports to meet MDR requirements and maintain the validity of your clinical evidence post-market.

Yes. We collaborate with your internal team to help establish SOPs, templates, and workflows aligned with MDR clinical evaluation requirements and integrate them into your quality system.

Yes. If a Notified Body raises concerns during review, we can assist in addressing feedback, performing gap analyses, and updating your CER or PMCF documentation to resolve issues efficiently.

We support clinical evaluations for all device classes, from low-risk Class I devices to high-risk Class III and implantable products.

Get in touch for an initial consultation. We’ll review your product and regulatory status, then provide a tailored proposal for CER development, review, or ongoing clinical support.

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